MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number FUSION

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that it was determined that the monitor and computer required replacement.It was also noted that the primary and secondary video ports were found to be inverted.The system then passed the system checkout and was found to be fully functional.The monitor was returned to the manufacturer for analysis.Analysis found that the returned monitor displayed a good image when connected to a known good system.The monitor ran for over three hours with no issue.No fault was found.The computer has been returned to the manufacturer and is currently under analysis.

Event Description

Medtronic received information regarding a navigation system.It was reported that the system randomly displayed ¿no input detected¿.No specific task was correlated with this system behavior.All of the cables were verified to be properly seated to the monitor, and to the back of the computer.This issue was discovered outside of a procedure and there was no patient present when this issue was identified.

Manufacturer Narrative

Initial reporter updated to proper value.

Manufacturer Narrative

The analysis of the computer for the navigation system was completed by medtronic personnel.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7886862
• MDR Text Key: 120694923
• Report Number: 1723170-2018-04789
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 09/18/2018; 09/18/2018
• Supplement Dates FDA Received: 09/20/2018; 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1